Outcomes of Direct Oral Anticoagulants in Patients With Mitral Stenosis

• Published in: Journal of the American College of Cardiology 2019-03, Vol.73 (10), p.1123-1131
• Main Authors: Kim, Ju Youn, Kim, Sung-Hwan, Myong, Jun-Pyo, Kim, Yoo Ri, Kim, Tae-Seok, Kim, Ji-Hoon, Jang, Sung-Won, Oh, Yong-Seog, Lee, Man Young, Rho, Tai-Ho
• Format: Article
• Language: English
• Subjects: Age; Aged; Anticoagulants; Anticoagulants - administration & dosage; Anticoagulants - adverse effects; atrial fibrillation; Atrial Fibrillation - complications; Atrial Fibrillation - drug therapy; Atrial Fibrillation - epidemiology; Cardiac arrhythmia; Cardiology; Cardiovascular disease; Chronic obstructive pulmonary disease; Codes; Confidence intervals; Diabetes; Embolisms; Female; Fibrillation; Health insurance; Heart failure; Hemorrhage; Hemorrhage - chemically induced; Hemorrhage - epidemiology; Humans; Hypertension; Insurance Claim Review - statistics & numerical data; intracranial hemorrhage; Ischemia; ischemic stroke; Male; Males; Middle Aged; mitral stenosis; Mitral Valve Stenosis - complications; Mitral Valve Stenosis - diagnosis; Mitral Valve Stenosis - drug therapy; Mitral Valve Stenosis - epidemiology; Patients; Population; Population studies; Prostheses; Republic of Korea - epidemiology; Severity of Illness Index; Software; Statistical analysis; Stenosis; Stroke; Stroke - etiology; Stroke - prevention & control; Studies; Surgery; systemic embolism; Thromboembolism; Thromboembolism - epidemiology; Thromboembolism - etiology; Thromboembolism - prevention & control; Warfarin
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2018.12.047

Patients with mitral stenosis and atrial fibrillation (AF) require anticoagulation for stroke prevention. Thus far, all studies on direct oral anticoagulants (DOACs) have excluded patients with moderate to severe mitral stenosis. The aim of this study was to validate the efficacy of DOACs in patients with mitral stenosis. The study population was enrolled from the Health Insurance Review and Assessment Service (HIRA) database in the Republic of Korea, and it included patients who were diagnosed with mitral stenosis and AF and either were prescribed DOACs for off-label use or received conventional treatment with warfarin. The primary efficacy endpoint was ischemic strokes or systemic embolisms, and the safety outcome was intracranial hemorrhage. A total of 2,230 patients (mean age 69.7 ± 10.5 years; 682 [30.6%] males) were included in the present study. Thromboembolic events occurred at a rate of 2.22%/year in the DOAC group, and 4.19%/year in the warfarin group (adjusted hazard ratio for DOAC: 0.28; 95% confidence interval: 0.18 to 0.45). Intracranial hemorrhage occurred in 0.49% of the DOAC group and 0.93% of the warfarin group (adjusted hazard ratio for DOAC: 0.53; 95% confidence interval: 0.22 to 1.26). In patients with AF accompanied with mitral stenosis, DOAC use is promising and hypothesis generating in preventing thromboembolism. Our results need to be replicated in a randomized trial. [Display omitted]